html 1/12

Size: px
Start display at page:

Download "https://rm2.scinet.fda.gov/druglabel/rs/spl/by-id/207036/ html 1/12"

Transcription

1 NEURACEQ - florbetaben f-18 injection, solution Piramal Imaging, SA HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEURACEQ safely and effectively. See full prescribing information for NEURACEQ. NEURACEQ (florbetaben F 18 injection), for intravenous use Initial U.S. Approval: 2014 INDICATIONS AND USAGE Neuraceq is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq have not been established for: Predicting development of dementia or other neurologic conditions Monitoring responses to therapies Use appropriate radiation handling measures (2.1). Administer 300 MBq (8.1 mci) as a slow single intravenous bolus (6 sec/ml) in a total volume of up to 10 ml (2.2) Obtain minute PET images starting from 45 to 130 minutes after intravenous administration (2.3) Image interpretation: refer to full prescribing information (2.4) The radiation absorbed dose from a 300 MBq (8.1 mci) dose of Neuraceq is 5.8 msv in an adult (2.5) DOSAGE AND ADMINISTRATION DOSAGE FORMS AND STRENGTHS 30 ml multi dose vials containing a clear injectable solution at a strength of 50 to 5000 MBq/mL (1.4 to135 mci/ml) florbetaben F18 at End Of Synthesis (EOS). At time of administration 300 MBq (8.1 mci) are contained in up to 10 ml solution for injection. None CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Image interpretation errors (especially false positives) have been observed (5.1). Neuraceq, like all radiopharmaceuticals, contributes to a patient s long term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure (5.2). ADVERSE REACTIONS The most commonly reported adverse reactions were: injection site reaction consisting of erythema (1.7 %), irritation (1.2 %), and pain (3.9 %). To report SUSPECTED ADVERSE REACTIONS, contact Piramal at or FDA at FDA 1088 or See 17 for PATIENT COUNSELING INFORMATION Revised: 05/2016 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Radiation Safety - Drug Handling 2.2 Recommended Dosing and Administration Instructions 2.3 Image Acquisition Guidelines 2.4 Image Display and Interpretation 2.5 Radiation Dosimetry 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Risk for Image Misinterpretation and Other Errors 5.2 Radiation Risk 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 11.1 Physical Characteristics 11.2 External Radiation 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION 1/12

2 NEURACEQ 30 ML VIAL LABEL (ZEVACOR) NEURACEQ 30 ML VIAL LABEL (N-MOLECULAR) NEURACEQ SHIELD LABEL FOR 30 ML VIAL (ZEVACOR) NEURACEQ SHIELD LABEL FOR 30 ML VIAL (N-MOLECULAR) * Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq have not been established for: Predicting development of dementia or other neurologic conditions; Monitoring responses to therapies. 2 DOSAGE AND ADMINISTRATION 2.1 Radiation Safety - Drug Handling Neuraceq is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2)]. Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling and administering Neuraceq. Radiopharmaceuticals, including Neuraceq, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. 2.2 Recommended Dosing and Administration Instructions The recommended dose of Neuraceq is 300 MBq (8.1 mci), maximum 30 mcg mass dose, administered as a single slow intravenous bolus (6 sec/ml) in a total volume of up to 10 ml. - Inspect the radiopharmaceutical dose solution prior to administration and do not use it if it contains particulate matter - Use aseptic technique and radiation shielding to withdraw and administer Neuraceq solution. - Measure the activity of Neuraceq with a dose calibrator immediately prior to injection. - Do not dilute Neuraceq - The injection must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artifacts. Verify patency of the indwelling catheter by a saline test injection prior to administration of Neuraceq. - An injection (6 sec/ml) into a large vein in the arm is recommended, followed by a saline flush of approximately 10 ml. - Dispose of unused product in a safe manner in compliance with applicable regulations 2.3 Image Acquisition Guidelines Acquire PET images over 15 to 20 minutes starting 45 to 130 minutes after Neuraceq injection. Keep the patient supine with the head positioned to center the brain, including the cerebellum, in the PET scanner field of view. Reduce head movement with tape or other flexible head restraints if necessary. Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2 and 3 mm. 2.4 Image Display and Interpretation Neuraceq images should be interpreted only by readers who successfully complete Electronic Media- or In-Person Training provided by the manufacturer [see Warnings and Precautions (5.1)]. The objective of Neuraceq image interpretation is to estimate β-amyloid neuritic plaque density in brain gray matter, not to make a clinical diagnosis. Image interpretation is performed independently of a patient s clinical features and relies upon the recognition of image features in certain brain regions. Image Display PET images should be displayed in the transaxial orientation using gray scale or inverse gray scale. The sagittal and coronal planes may be used for additional orientation purposes. CT or MR images may be helpful for anatomic reference purposes. However, visual assessment should be performed using the axial planes according to the recommended reading methodology. Image Interpretation Interpretation of the images is made by visually comparing the activity in cortical gray matter with activity in adjacent white matter. Regions displayed in the PET images which anatomically correspond to white matter structures (e.g., the cerebellar white matter or the splenium) should be identified to help the readers orient themselves. Images should be viewed and assessed in a systematic manner, starting with the cerebellum and scrolling up through the lateral temporal and frontal lobes, the posterior cingulate cortex/precuneus, and the parietal lobes. For a gray matter cortical region to be assessed as showing tracer uptake, the majority of slices from the respective region must be affected. For each patient, the PET image assessment is categorized as either β-amyloid-positive or β-amyloid-negative. This determination is based on the assessment of tracer uptake in the gray matter of the following four brain regions: the temporal lobes, the frontal lobes, the posterior cingulate cortex/precuneus, and the parietal lobes; according to the following rules for assessment [see Warnings and Precautions (5.1)]: β-amyloid negative - tracer uptake (i.e., signal intensity) in gray matter is lower than in white matter in all four brain regions (no β-amyloid deposition) 2/12

3 β-amyloid positive - smaller area(s) of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within at least one of the four brain regions ( moderate β-amyloid deposition), or a large confluent area of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin and involving the entire region including the majority of slices within at least one of the four brain regions ( pronounced β-amyloid deposition). There is no known clinical or histopathologic correlation distinguishing moderate from pronounced β-amyloid deposition. Examples of positive and negative scans for each of the four brain regions are illustrated in Figure 1. Figure 1 Axial view of negative (top row) and positive (bottom row) Neuraceq PET scans Cerebellum: A contrast between the white matter (arrows) and gray matter is seen in both negative and positive scans. Extracerebral tracer uptake in scalp and in the posterior sagittal sinus (arrowhead) can be seen. Lateral temporal lobes: Spiculated or mountainous appearance of the white matter (arrows) is seen in the negative scan, and radioactive signal does not reach the outer rim of the brain (dashed line) due to lower tracer uptake in the gray matter. The positive scan shows a plumped, smooth appearance of the outer border of the brain parenchyma (dashed line) due to tracer uptake in the gray matter. Frontal Lobes: Spiculated appearance of the white matter in the frontal lobes (arrows) is seen in the negative scan. The positive scan shows the tracer uptake in these regions has a plumped, smooth appearance due to the increased gray matter signal (dashed line). Posterior cingulate/precuneus: Adjacent and posterior to the splenium (arrow), these regions appear as a hypo-intense hole (circle) in the negative scan, whereas this hole is filled-up (circle) in the positive scan. Parietal lobes: In the negative scan, the midline between the parietal lobes can be easily identified (long arrow); white matter has a spiculated appearance (short arrow) with low signal near the outer rim of the brain (dashed line). In the positive scan, the midline between the parietal lobes is much thinner. The cortical areas are filled-up and are smooth in appearance as tracer uptake extends to the outer rim of the brain. Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortex, or image blur. If a co-registered computerized tomography (CT) image is available, the CT image may be used to clarify the relationship of the Neuraceq uptake and the gray matter anatomy. 2.5 Radiation Dosimetry The estimated radiation absorbed doses for adults from intravenous injection of Neuraceq are shown in Table 1. Table 1 Estimated Radiation Absorbed Doses from Intravenous Injection of Neuraceq Organ/Tissue Mean Absorbed Radiation Dose per Unit Administered Activity [mcgy/mbq] Adrenals 13 Brain 13 Breasts 7 Gallbladder Wall 137 Heart Wall 14 Kidneys 24 Liver 39 Lower Large Intestine-Wall 35 Lungs 15 Muscle 10 Osteogenic Cells 15 Ovaries 16 Pancreas 14 Red Marrow /12

4 Skin 7 Small Intestine 31 Spleen 10 Stomach Wall 12 Testes 9 Thymus 9 Thyroid 8 Upper Large Intestine-Wall 38 Urinary Bladder Wall 70 Uterus 16 Total Body 11 Effective Dose (mcsv/mbq) 19 The effective dose resulting from a 300 MBq (8.1 mci) administration of Neuraceq in adult subjects is 5.8 msv. The use of a CT scan to calculate attenuation correction for reconstruction of Neuraceq images (as done in PET/CT imaging) will add radiation exposure. Diagnostic head CT scans using helical scanners administer an average of 2.2 ± 1.3 msv effective dose (CRCPD Publication E-07-2, 2007). The actual radiation dose is operator and scanner dependent. Thus, the total combined radiation exposure from Neuraceq administration and subsequent scan on a PET/CT scanner is estimated to be 8 msv. 3 DOSAGE FORMS AND STRENGTHS Neuraceq is available in 30 ml multi-dose vials containing a clear solution at a strength of MBq/mL ( mci/ml) florbetaben F18 at EOS. At time of administration 300 MBq (8.1 mci) are contained in up to 10 ml of solution for injection. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Risk for Image Misinterpretation and Other Errors Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future. 5.2 Radiation Risk Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration (2.1)]. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in clinical practice. The overall safety profile of Neuraceq is based on data from 978 administrations of Neuraceq to 872 subjects and 12 subjects who received vehicle only. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema, irritation and pain. All adverse reactions were mild to moderate in severity and of short duration. The most commonly reported adverse reactions (occurring in at least 0.5% of subjects) during Neuraceq clinical trials are shown in Table 2. Table 2 Adverse Reactions with a Frequency 0.5% Reported in Clinical Trials (n = 978 Administrations in 872 Subjects) Adverse drug reaction n (%) Injection / application site erythema 17 (1.7) Injection site irritation 12 (1.2) Injection site pain 38 (3.9) 7 DRUG INTERACTIONS Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: It is not known whether Neuraceq can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with Neuraceq. All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Neuraceq should be given to a pregnant woman only if clearly needed. Assess pregnancy status before administering Neuraceq to a female of reproductive potential. 4/12

5 8.3 Nursing Mothers It is not known whether Neuraceq is excreted in human milk. Because many drugs are excreted into human milk and because of the potential for radiation exposure to nursing infants from Neuraceq, avoid use of the drug in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) after exposure to Neuraceq. If breastfeeding is interrupted, the patient should pump and discard her breast milk and use alternate nutrition sources (e.g. stored breast milk or infant formula) for 24 hours after the administration of Neuraceq. 8.4 Pediatric Use Neuraceq is not indicated for use in pediatric patients. 8.5 Geriatric Use Of the 872 subjects in clinical studies of Neuraceq, 603 (69%) were 65 years or over, while 304 (35%) were 75 years or over. No overall differences in safety were observed between these subjects and younger subjects. 10 OVERDOSAGE A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. 11 DESCRIPTION Neuraceq contains florbetaben F18, a molecular imaging agent that binds to β-amyloid plaques in the brain, and is intended for use with PET imaging. Chemically, florbetaben F18 is described as 4-[(E)-2-(4-{2-[2-(2-[ 18F] fluoroethoxy) ethoxy] ethoxy}phenyl)vinyl]-n-methylaniline. The molecular weight is and the structural formula is: Neuraceq is a sterile, non-pyrogenic radioactive diagnostic agent for intravenous injection. The clear solution is supplied ready to use. Each ml contains up to 3 micrograms and MBq ( mci) florbetaben F18 EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol 400, 28.8 mg sodium ascorbate. The ph of the solution is between 4.5 and Physical Characteristics Neuraceq is radiolabeled with [ 18 F] fluorine (F18) that decays by positron (ß + ) emission to O 18 and has a half-life of minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 kev gamma photons resulting from the interaction of the emitted positron with an electron (Table 3). Table 3: Principal Radiation Produced from Decay of Fluorine 18 Radiation Energy Level (kev) Abundance (%) Positron Gamma External Radiation The point source air-kerma coefficient a for F18 is 3.74E -17 Gy m 2/ (Bq s); this coefficient was formerly defined as the specific gamma-ray constant of 5.7 R/hr/mCi at 1 cm. The first half-value thickness of lead for F18-fluorine gamma rays is approximately 6 mm b. The relative reduction of radiation emitted by F18-fluorine that results from various thicknesses of lead shielding is shown in Table 4. The use of ~8 cm of lead (Pb) will decrease the radiation transmission (i.e. exposure) by a factor of about 10,000. Table 4: Radiation Attenuation of 511 kev Gamma Rays by Lead Shielding Shield Thickness cm of Lead (Pb) Coefficient of Attenuation aeckerman KF and A Endo. MIRD: Radionuclide Data and Decay Schemes, 2nd Edition, bderived from data in NCRP Report No , Appendix C 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Florbetaben F18 is a F18-labeled stilbene derivative, which binds to β-amyloid plaques in the brain. The F 18 isotope produces a positron signal that is detected by a PET scanner. 3H-florbetaben in vitro binding experiments reveal two binding sites (Kd of 16 nm and 135 nm) in frontal cortex homogenates from patients with AD. Binding of florbetaben F18 to β-amyloid plaques in post-mortem brain sections from patients with AD using autoradiography correlates with both immunohistochemical and Bielschowsky silver stains. Florbetaben F 18 does not bind to tau or α-synuclein in tissue from patients with AD. Neither Neuraceq nor non-radioactive florbetaben F 19 bind to AT8 positive tau deposits in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively. 5/12

6 12.2 Pharmacodynamics Following intravenous administration, Neuraceq crosses the blood brain barrier and shows differential retention in brain regions that contain β-amyloid deposits. Differences in signal intensity between brain regions showing specific and non-specific Neuraceq uptake form the basis for the image interpretation method Pharmacokinetics Ten minutes after intravenous bolus injection of 300 MBq of Neuraceq in human volunteers, approximately 6% of the injected radioactivity was distributed to the brain. Florbetaben F 18 plasma concentrations declined by approximately 75% at 20 minutes post-injection, and by approximately 90% at 50 minutes. The F 18 in circulation during the minute imaging window was principally associated with polar metabolites of florbetaben. Florbetaben F 18 was 98.5% bound to plasma proteins and was eliminated from plasma primarily via the hepatobiliary route with a mean biological halflife of approximately 1 hour. In vitro studies show that metabolism of florbetaben is predominantly catalyzed by CYP2J2 and CYP4F2. At 12 hours postadministration, approximately 30% of the injected radioactivity had been excreted in urine. Almost all F18 radioactivity in urine was excreted as polar metabolites of florbetaben F18 and only trace amounts of florbetaben F18 were detected. In in vitro studies using human liver microsomes, florbetaben did not inhibit cytochrome P450 enzymes at concentrations present in vivo. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been performed to evaluate the carcinogenic potential of florbetaben. Florbetaben did not demonstrate mutagenic potential in an in vitro bacterial mutation assay (Ames test) using five strains of Salmonella typhimurium and one strain of Escherichia coli or in an in vitro chromosomal aberration assay using human peripheral lymphocytes in the absence and presence of a metabolic activator. No study on impairment of male or female fertility and reproductive performance was conducted in animals. 14 CLINICAL STUDIES Neuraceq was evaluated in three single arm clinical studies (Study A-C) that examined images from adults with a range of cognitive function, including some end-of-life patients who had agreed to participate in a post-mortem brain donation program. Subjects underwent Neuraceq injection and scan, then had images interpreted by independent readers masked to all clinical information. The Standard of Truth (SoT) was based on the histopathologic examination using Bielschowsky silver staining (BSS) of six brain regions assessed by a Pathology Consensus Panel masked to all clinical information (including PET scan results). Neuraceq PET imaging results (negative or positive) corresponded to a histopathology derived plaque score based on the Consortium to Establish a Registry for Alzheimer s Disease (CERAD) criteria using neuritic plaque counts (Table 5). For the subject level SoT, if in any of the six regions β-amyloid neuritic plaques were more than sparse, the subject was classified as positive; if in none of the regions the β-amyloid neuritic plaques were assessed as being more than sparse, the subject was classified as negative. Table 5: ß-Amyloid Neuritic Plaque Counts Correlation to Image Results Plaque Counts CERAD Score Neuraceq PET Image Result <1 None 1-5 Sparse 6-19 Moderate 20 Frequent Negative Positive Study A evaluated Neuraceq PET images from 205 subjects and compared the results to postmortem truth standard assessments of brain β-amyloid neuritic plaque density in subjects who died during the study. The median age was 79 years (range 48 to 98 years) and 52% of the subjects were male. By medical history 137 study participants had AD, 31 had other non-ad dementia, 5 had dementia with Lewy Bodies (DLB), and 32 had no clinical evidence of dementia. Interpretation of images from 82 autopsied subjects was compared to the subject level histopathology SoT. Three readers, after undergoing in-person tutoring, interpreted images using a clinically applicable image interpretation methodology [see Dosage and Administration (2.4)]. At autopsy, the subject level brain β-amyloid neuritic plaque density category was: frequent (n = 31); moderate (n = 21); sparse (n = 17); or none (n = 13). Results from Study A are presented in Table 6 and Table 7. In Study B five independent, blinded readers underwent the Electronic Media Training in the clinically applicable image interpretation methodology [see Dosage and Administration (2.4)] and assessed images from the same 82 end-of-life subjects who enrolled in Study A. The time interval between the Neuraceq scan and death was less than one year for 45 patients, between one and two years for 23 patients and more than two years for 14 patients. Results from Study B can also be found in Table 6 and Table 7. Study C evaluated the reliability and reproducibility of the clinically applicable image interpretation methodology [see Dosage and Administration (2.4)] using the Electronic Media Training; 461 images from previous clinical studies were included from subjects with a range of diagnoses. Five new readers assessed randomly provided images from subjects with a truth standard (54 subjects who underwent an autopsy) and without a truth standard (51 subjects with mild cognitive impairment, 182 subjects with AD, 35 subjects with other dementias, 5 subjects with Parkinson s Disease and 188 healthy volunteers). Among the 461 subjects, the median age was 72 years (range 22 to 98), 197 were females, and 359 were Caucasian. Image reproducibility data for various subject groups in Study C are presented in Table 8. Inter-reader agreement across all 5 readers had a kappa coefficient of 0.79 (95% CI 0.77, 0.83). The performance characteristics in 54 subjects with SoT were similar to those measured in Studies A and B. Additionally, intra-reader reproducibility was assessed from 46 images (10%); the percentage of intra- reader agreement for the 5 readers ranged from 91% to 98%. Table 6: Neuraceq Results by Reader Training Method using BSS as Standard of Truth Read Result In-Person Training (Study A) Electronic Media Training (Study B) n=82 n=82 Sensitivity (%) Median Range among the readers Specificity (%) Median Range among the readers Table 7: Neuraceq Correct and Erroneous Read Results by Reader Training Method 6/12

7 In-Person Training (Study A) Electronic Media Training (Study B) Read Result Reader Reader Correct False Negative False Positive BSS was the Histopathology Standard of Truth Table 8: Reproducibility of Scan Results among Readers in Various Subject Groupsa Subject Group by Cognitive Status and Standard of Truth (SoT) Positive Scans nb All subjects (n=454) 212 Subjects without SoT (n=394) 175 Subjects with SoT (n=60) 37 AD (n=176) 139 HV (n=188) 26 MCI (n=50, all without SoT) 28 Other Dementias (n=40) 18 Kappa (95% CI) 0.80 (0.77, 0.83) 0.80 (0.77, 0.83) 0.75 (0.67, 0.83) 0.77 (0.72, 0.81) 0.55 (0.49, 0.58) 0.84 (0.75, 0.92) 0.65 (0.55, 0.74) Percent of Scans with Inter-reader Agreement 3 of 5 readers agreed 4 of 5 readers agreed 5 of 5 readers agreed asubjects with missing scan interpretation (2 to 6% per group) were excluded from the analyses. bshown is the median number of scans interpreted as positive across the 5 readers for each group of subjects listed in the first column. Alzheimer s disease (AD), Mild cognitive impairment (MCI), healthy volunteer (HV). Other dementias include DLB, fronto-temporal lobe dementia, vascular dementia, and dementia associated with PD. 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Neuraceq is supplied in a 30 ml glass vial containing up to 30 ml of a clear solution at a strength of 50 to 5000 MBq/mL (1.4 to 135 mci/ml) florbetaben F18 at EOS. Each vial contains multiple doses and is enclosed in a shielded container to minimize external radiation exposure Storage and Handling Store Neuraceq at room temperature 25 C (77 F); excursions permitted to 2 C to 42 C (36 F to 108 F). The product does not contain a preservative. Store Neuraceq within the original container or equivalent radiation shielding. Neuraceq must not be diluted. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. 17 PATIENT COUNSELING INFORMATION Instruct patients to inform their physician or healthcare provider if they are pregnant or breastfeeding. Inform patients who are breastfeeding to use alternate infant nutrition sources (e.g. stored breast milk or infant formula) for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) after administration of the drug or to avoid use of the drug. Manufactured for Piramal Imaging, S.A., Route de l Ecole 13, 1753 Matran Switzerland Neuraceq is a trademark of Piramal Imaging. Neuraceq 30 ml Vial Label (Zevacor) NDC Neuraceq Florbetaben F18 injection 30 ml Multiple-Dose Vial Sterile Non-Pyrogenic Rx ONLY 7/12

8 Rx ONLY CAUTION RADIOACTIVE MATERIAL Activity at *EOS MBq ( mci) in ml at : on Expiration Date/Time (Expires 10 Hours after *EOS) Concentration at *EOS mci/ml Diagnostic - For Intravenous Use Only Volume: 29mL Batch No.: Date: Each ml contains up to 3 mcg of florbetaben and MBq/mL ( mci/ml) florbetaben F18 at *EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol (PEG400), 28.8 mg sodium ascorbate, mg water for injection. *EOS - End of Synthesis Store at room temperature 25 C (77 F); excursions permitted to 2 C to 42 C (36 F 108 F). Store upright. Do not use if it is cloudy or contains particulate matter. Manufactured by Zevacor Pharma, Inc., Atlantic Blvd., Ste. 730, Dulles, VA for Piramal Imaging SA SPF-061-V03 Neuraceq 30 ml Vial Label (N-Molecular) NDC Neuraceq Florbetaben F18 injection 30 ml Multiple-Dose Vial Sterile Non-Pyrogenic Rx ONLY CAUTION RADIOACTIVE MATERIAL Activity at *EOS MBq ( mci) in ml at : on Expiration Date/Time (Expires 10 Hours after *EOS) Concentration at *EOS mci/ml Diagnostic - For Intravenous Use Only Volume: 29mL Batch No.: Date: Each ml contains up to 3 mcg of florbetaben and MBq/mL ( mci/ml) florbetaben F18 at *EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol (PEG400), 28.8 mg sodium ascorbate, mg water for injection. *EOS - End of Synthesis Store at room temperature 25 C (77 F); excursions permitted to 2 C to 42 C (36 F 108 F). Store upright. Do not use if it is cloudy or contains particulate matter. Manufactured by N-Molecular, Inc., Atlantic Blvd., Ste. 730, Dulles, VA for Piramal Imaging SA SPF-061-V03 8/12

9 Neuraceq Shield Label for 30 ml Vial (Zevacor) NDC Neuraceq Florbetaben F18 injection 30 ml Multiple-Dose Vial Sterile Non-Pyrogenic Rx ONLY CAUTION RADIOACTIVE MATERIAL Activity at *EOS MBq ( mci) in ml at : on Batch No.: Date: Expiration Date/Time (Expires 10 Hours after *EOS) Concentration at *EOS mci/ml Diagnostic - For Intravenous Use Only Volume: 29mL Each ml contains up to 3 mcg of florbetaben and MBq/mL ( mci/ml) florbetaben F18 at *EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol (PEG400), 28.8 mg sodium ascorbate, mg water for injection. See package insert for dosage information. Dispense aseptically into a sterile syringe or other sterile container within a lead shielded secondary container. Store room temperature 25 C (77 F); excursions permitted to 2 C to 42 C (36 F 108 F). Store upright. Do not use if it is cloudy or contains particulate matter. *EOS - End of Synthesis Manufactured by Zevacor Pharma, Inc., Atlantic Blvd., Ste. 730, Dulles, VA for Piramal Imaging SA SPF-060-V03 9/12

10 Neuraceq Shield Label for 30 ml Vial (N-Molecular) NDC Neuraceq Florbetaben F18 injection 30 ml Multiple-Dose Vial Sterile Non-Pyrogenic Rx ONLY CAUTION RADIOACTIVE MATERIAL Activity at *EOS MBq ( mci) in ml at : on Batch No.: Date: Expiration Date/Time (Expires 10 Hours after *EOS) Concentration at *EOS mci/ml Diagnostic - For Intravenous Use Only Volume: 29mL Each ml contains up to 3 mcg of florbetaben and MBq/mL ( mci/ml) florbetaben F18 at *EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol (PEG400), 28.8 mg sodium ascorbate, mg water for injection. See package insert for dosage information. Dispense aseptically into a sterile syringe or other sterile container within a lead shielded secondary container. Store room temperature 25 C (77 F); excursions permitted to 2 C to 42 C (36 F 108 F). Store upright. Do not use if it is cloudy or contains particulate matter. *EOS - End of Synthesis Manufactured by N-Molecular, Inc., Atlantic Blvd., Ste. 730, Dulles, VA for Piramal Imaging SA SPF-060-V /12

11 NEURACEQ florbetaben f 18 injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLORBETABEN F-18 (FLORBETABEN F-18) FLORBETABEN F mci in 1 ml Inactive Ingredients Ingredient Name ALCOHOL POLYETHYLENE GLYCOL 400 ASCORBIC ACID SODIUM ASCORBATE WATER Strength 118 mg in 1 ml 200 mg in 1 ml 4.4 mg in 1 ml 28.8 mg in 1 ml mg in 1 ml Product Characteristics Color Score Shape Flavor Contains Size Imprint Code Packaging # Item Code Package Description Multilevel Packaging 1 NDC: VIAL, MULTI-DOSE in 1 CONTAINER contains a VIAL, MULTI-DOSE 1 30 ml in 1 VIAL, MULTI-DOSE This package is contained within the CONTAINER ( ) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 11/12

12 NDA NDA /20/2014 Labeler - Piramal Imaging, SA ( ) Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production Zevacor Pharma, Inc. dba Zevacor positron emission tomography drug production N-Molecular, Inc. dba Zevacor positron emission tomography drug production N-Molecular, Inc. dba Zevacor positron emission tomography drug production Revised: 05/2016 Piramal Imaging, SA 12/12

NEURACEQ (florbetaben F 18 injection), for intravenous use Initial U.S. Approval: 2014

NEURACEQ (florbetaben F 18 injection), for intravenous use Initial U.S. Approval: 2014 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEURACEQ safely and effectively. See full prescribing information for NEURACEQ. NEURACEQ (florbetaben

More information

PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION. NeuraCeq. Florbetaben ( 18 F) 3 µg/ml Solution for Intravenous Administration

PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION. NeuraCeq. Florbetaben ( 18 F) 3 µg/ml Solution for Intravenous Administration PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NeuraCeq Florbetaben ( 18 F) 3 µg/ml Solution for Intravenous Administration Diagnostic Radiopharmaceutical IsoLogic Innovative Radiopharmaceuticals

More information

Page 1 of CONTRAINDICATIONS None (4)

Page 1 of CONTRAINDICATIONS None (4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AXUMIN safely and effectively. See full prescribing information for AXUMIN. AXUMIN (fluciclovine

More information

To report suspected adverse reactions to Axumin, call AXUMIN1 ( ) or contact FDA at FDA-1088 or

To report suspected adverse reactions to Axumin, call AXUMIN1 ( ) or contact FDA at FDA-1088 or An Axumin scan can detect and localize recurrent prostate cancer Axumin is an FDA-approved diagnostic imaging agent, also known as a tracer, which may help your physician determine if and where your prostate

More information

Vizamyl Flutemetamol F 18 Injection

Vizamyl Flutemetamol F 18 Injection Vizamyl Flutemetamol F 18 Injection HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VIZAMYL safely and effectively. See full prescribing information

More information

INDICATIONS AND USAGE

INDICATIONS AND USAGE 1. INDICATIONS AND USAGE a) Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following

More information

GALLIUM CITRATE Ga 67 INJECTION

GALLIUM CITRATE Ga 67 INJECTION 511945-0903 September 2003 USA Bristol-Myers Squibb Medical Imaging 331 Treble Cove Road N. Billerica, MA 01862 USA GALLIUM CITRATE Ga 67 INJECTION FOR DIAGNOSTIC USE DESCRIPTION: Gallium Citrate Ga 67

More information

FP/1-61//- p-o37 A mb. Precision Nuclear, LLC. July 7, 2011

FP/1-61//- p-o37 A mb. Precision Nuclear, LLC. July 7, 2011 211 JUL Ili A II 5b Precision Nuclear, LLC July 7, 211 Amendment to Citizen Petition docket no. FDA-211-P-337-1/CP filed on 5/6/211 I, Jon L. McReynolds, PharmD, representing Precision Nuclear, LLC submit

More information

Sodium Iodide I 131 Solution. Click Here to Continue. Click Here to Return to Table of Contents

Sodium Iodide I 131 Solution. Click Here to Continue. Click Here to Return to Table of Contents Sodium Iodide I 131 Solution Package inserts are current as of January, 1997. Contact Professional Services, 1-888-744-1414, regarding possible revisions Click Here to Continue Click Here to Return to

More information

Click Here to Continue. Click Here to Return to Table of Contents

Click Here to Continue. Click Here to Return to Table of Contents TechneScan Gluceptate Package inserts are current as of January, 1997. Contact Professional Services, 1-888-744-1414, regarding possible revisions. Click Here to Continue Click Here to Return to Table

More information

GLUCEPTATE. Technetium Tc 99m Gluceptate Kit DIAGNOSTIC DESCRIPTION

GLUCEPTATE. Technetium Tc 99m Gluceptate Kit DIAGNOSTIC DESCRIPTION 27194 0001E m TM GLUCEPTATE Technetium Tc 99m Gluceptate Kit DIAGNOSTIC DESCRIPTION The kit consists of reaction vials which contain the sterile, non-pyrogenic, nonradioactive ingredients necessary to

More information

Sodium Fluoride F 18 Injection* PET/CT Imaging

Sodium Fluoride F 18 Injection* PET/CT Imaging Sodium Fluoride F 18 Injection* PET/CT Imaging for Prostate Cancer Sodium Fluoride F 18 Injection* ( 18 F NaF) PET/CT Imaging of Bone Metastases in Prostate Cancer About Prostate Cancer According to the

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Amyvid 800 MBq/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains

More information

Click Here to Continue. Click Here to Return to Table of Contents

Click Here to Continue. Click Here to Return to Table of Contents Hippuran I 131 Injection Package inserts are current as of January, 1997. Contact Professional Services, 1-888-744-1414, regarding possible revisions Click Here to Continue Click Here to Return to Table

More information

TABLE 1 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (kev) Gamma

TABLE 1 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (kev) Gamma KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN - mebrofenin injection, powder, lyophilized, for solution ---------- Kit for the Preparation of Technetium Tc 99m Mebrofenin DESCRIPTION Each multidose

More information

DRAXIMAGE MDP-25 Kit for the Preparation of Technetium Tc 99m Medronate Injection. For Intravenous Use DIAGNOSTIC FOR SKELETAL IMAGING

DRAXIMAGE MDP-25 Kit for the Preparation of Technetium Tc 99m Medronate Injection. For Intravenous Use DIAGNOSTIC FOR SKELETAL IMAGING TECHNETIUM TC 99M MEDRONATE - medronic acid injection, powder, for solution Jubilant DraxImage Inc ---------- DRAXIMAGE MDP-25 Kit for the Preparation of Technetium Tc 99m Medronate Injection For Intravenous

More information

R: March, E D T P A. Kit for the Preparation of Technetium Tc 99m Pentetate Injection. DIAGNOSTIC - For Intravenous Use

R: March, E D T P A. Kit for the Preparation of Technetium Tc 99m Pentetate Injection. DIAGNOSTIC - For Intravenous Use R: March, 1998 27227 0002E m TM DESCRIPTION D T P A Kit for the Preparation of Technetium Tc 99m Pentetate Injection DIAGNOSTIC - For Intravenous Use Each kit consists of reaction vials which contain the

More information

PHYSICAL CHARACTERISTICS

PHYSICAL CHARACTERISTICS BRACCO DIAGNOSTICS L/4739/0 1 CHOLETEC Kit for the Preparation of Technetium Tc 99m Mebrofenin For Diagnostic Use DESCRIPTION Each reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture

More information

DRAXIMAGE SODIUM IODIDE I 131 CAPSULES, USP DIAGNOSTIC. For Oral Use DESCRIPTION

DRAXIMAGE SODIUM IODIDE I 131 CAPSULES, USP DIAGNOSTIC. For Oral Use DESCRIPTION DRAXIMAGE SODIUM IODIDE I 131 CAPSULES, USP DIAGNOSTIC For Oral Use DESCRIPTION Sodium Iodide I 131 Capsules, USP are color-coded capsules containing sodium iodide I 131 for diagnostic use by oral administration.

More information

DRAXIMAGE SODIUM IODIDE I 131 SOLUTION USP DIAGNOSTIC. For Oral Use DESCRIPTION

DRAXIMAGE SODIUM IODIDE I 131 SOLUTION USP DIAGNOSTIC. For Oral Use DESCRIPTION DRAXIMAGE SODIUM IODIDE I 131 SOLUTION USP DIAGNOSTIC For Oral Use DESCRIPTION Sodium Iodide I 131 Solution is an aqueous solution of sodium iodide I-131 for diagnostic use by oral administration. The

More information

Austin Radiological Association Nuclear Medicine Procedure PET SODIUM FLUORIDE BONE SCAN (F-18 NaF)

Austin Radiological Association Nuclear Medicine Procedure PET SODIUM FLUORIDE BONE SCAN (F-18 NaF) Austin Radiological Association Nuclear Medicine Procedure PET SODIUM FLUORIDE BONE SCAN (F-18 NaF) Overview Indication Sodium Fluoride F18 injection is a radioactive diagnostic agent for positron emission

More information

See 17 for PATIENT COUNSELING INFORMATION Vial 1 (reaction vial with lyophilized powder) containing 40 mcg of dotatate (3)

See 17 for PATIENT COUNSELING INFORMATION Vial 1 (reaction vial with lyophilized powder) containing 40 mcg of dotatate (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NETSPOT safely and effectively. See full prescribing information for NETSPOT. NETSPOT (kit for the

More information

Dose Calibration for DaTscan

Dose Calibration for DaTscan GE Healthcare Dose Calibration for DaTscan Please review the simple steps below to learn how to properly calibrate your dose of DaTscan. 1 2 3 4 5 6 7 8 9 Reading DaTscan in the Dose Calibrator 1. Place

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked

More information

3 DOSAGE FORMS AND STRENGTHS

3 DOSAGE FORMS AND STRENGTHS PATADAY- olopatadine hydrochloride solution/ drops Alcon Laboratories, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PATADAY safely

More information

ESKATA TM (hydrogen peroxide) topical solution Initial U.S. Approval: 2017

ESKATA TM (hydrogen peroxide) topical solution Initial U.S. Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ESKATA TM safely and effectively. See full prescribing information for ESKATA TM. ESKATA TM (hydrogen

More information

Austin Radiological Association Ga-68 NETSPOT (Ga-68 dotatate)

Austin Radiological Association Ga-68 NETSPOT (Ga-68 dotatate) Austin Radiological Association Ga-68 NETSPOT (Ga-68 dotatate) Overview Ga-68 dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2). It binds to cells that express

More information

CONTRAINDICATIONS None.

CONTRAINDICATIONS None. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAZEO safely and effectively. See full prescribing information for PAZEO. PAZEO (olopatadine hydrochloride

More information

Summary of Risk Management Plan (RMP)

Summary of Risk Management Plan (RMP) Summary of Risk Management Plan (RMP) Neuraceq Florbetaben ( 18 F), solution for injection SWAN Isotopen AG CH-3010 Bern The Risk Management Plan (RMP) is a comprehensive document submitted as part of

More information

ESKATA (hydrogen peroxide) topical solution Initial U.S. Approval: 2017

ESKATA (hydrogen peroxide) topical solution Initial U.S. Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ESKATA safely and effectively. See full prescribing information for ESKATA. ESKATA (hydrogen peroxide)

More information

Piramal Imaging to Present New Research in PET Imaging at Society of Nuclear Medicine and Molecular Imaging 2017 Annual Meeting

Piramal Imaging to Present New Research in PET Imaging at Society of Nuclear Medicine and Molecular Imaging 2017 Annual Meeting FOR IMMEDIATE RELEASE Media Contacts: Nicole Fletcher Piramal Imaging nicole.fletcher@piramal.com (857) 202-1122 Piramal Imaging to Present New Research in PET Imaging at Society of Nuclear Medicine and

More information

1/13

1/13 KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID - technetium tc 99m sulfur colloid Pharmalucence Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC (ferric

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics Sodium Phosphate ( 32 P) 18.5-185 MBq/ml Injection 1. NAME OF THE MEDICINAL PRODUCT Sodium Phosphate ( 32 P) 18.5-185 MBq/ml Injection 2. QUALITATIVE AND QUANTITATIVE

More information

(angiotensin II) injection for intravenous infusion

(angiotensin II) injection for intravenous infusion ADMINISTERING GIAPREZA TM (angiotensin II) injection for intravenous infusion Visit www.giapreza.com INITIATE Recommended starting dose of GIAPREZA is 20 ng/kg/min, which is equivalent to 0.02 mcg/kg/min

More information

ADVERSE REACTIONS The most common (>10%) adverse reactions are hypercalcemia, nausea, and diarrhea. (6.

ADVERSE REACTIONS The most common (>10%) adverse reactions are hypercalcemia, nausea, and diarrhea. (6. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PHOSLYRA safely and effectively. See full prescribing information for PHOSLYRA. PHOSLYRA (calcium

More information

1 INDICATIONS AND USAGE. 1.1 Limitation of Use FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE. 1.1 Limitation of Use FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC (ferric

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)

More information

*Sections or subsections omitted from the full prescribing information are not listed.

*Sections or subsections omitted from the full prescribing information are not listed. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GIAPREZA TM safely and effectively. See full prescribing information for GIAPREZA. GIAPREZA (angiotensin

More information

Supplementary Online Content

Supplementary Online Content Supplementary Online Content Curtis C, Gamez JE, Singh U, et al. Phase 3 trial of flutemetamol labeled with radioactive fluorine 18 imaging and neuritic plaque density. JAMA Neurol. Published online January

More information

SUMMARY OF PRODUCT CHARACTERISTICS. for. BRIDATEC, kit for radiopharmaceutical preparation

SUMMARY OF PRODUCT CHARACTERISTICS. for. BRIDATEC, kit for radiopharmaceutical preparation February 9, 2010 SUMMARY OF PRODUCT CHARACTERISTICS for BRIDATEC, kit for radiopharmaceutical preparation 1. NAME OF THE MEDICINAL PRODUCT BRIDATEC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION N-(3-bromo-2,4,6-trimethylphenylcarbamoyl

More information

ELSPAR (asparaginase) For injection, intravenous or intramuscular Initial U.S. Approval: 1978

ELSPAR (asparaginase) For injection, intravenous or intramuscular Initial U.S. Approval: 1978 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Elspar safely and effectively. See full prescribing information for Elspar. ELSPAR (asparaginase)

More information

HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use epinastine hydrochloride ophthalmic solution safely and effectively. See full prescribing information

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RADIOGENIX SYSTEM safely and effectively. See full prescribing information for RADIOGENIX TM SYSTEM.

More information

FULL PRESCRIBING INFORMATION: CONTENTS*

FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTIPRIO safely and effectively. See full prescribing information for OTIPRIO. OTIPRIO (ciprofloxacin

More information

SODIUM IODIDE I-131 THERAPEUTIC - sodium iodide i-131 solution MALLINCKRODT NUCLEAR MEDICINE LLC

SODIUM IODIDE I-131 THERAPEUTIC - sodium iodide i-131 solution MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM IODIDE I-131 THERAPEUTIC - sodium iodide i-131 solution MALLINCKRODT NUCLEAR MEDICINE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed

More information

VORAXAZE (glucarpidase) For Injection, for intravenous use Initial U.S. Approval: 2012

VORAXAZE (glucarpidase) For Injection, for intravenous use Initial U.S. Approval: 2012 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VORAXAZE safely and effectively. See full prescribing information for VORAXAZE. VORAXAZE (glucarpidase)

More information

CONTRAINDICATIONS None (4)

CONTRAINDICATIONS None (4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Cystadane safely and effectively. See full prescribing information for Cystadane. Cystadane (betaine

More information

Your guide to NETSPOT

Your guide to NETSPOT Your guide to NETSPOT A tool to help your doctors diagnose and plan the treatment of neuroendocrine tumors (NETs) NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for

More information

CONTRAINDICATIONS Hypersensitivity to any component of this product (4)

CONTRAINDICATIONS Hypersensitivity to any component of this product (4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OMIDRIA safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA (phenylephrine

More information

Yin-Hui Siow MD, FRCPC Director of Nuclear Medicine Southlake Regional Health Centre

Yin-Hui Siow MD, FRCPC Director of Nuclear Medicine Southlake Regional Health Centre Yin-Hui Siow MD, FRCPC Director of Nuclear Medicine Southlake Regional Health Centre Today Introduction to CT Introduction to MRI Introduction to nuclear medicine Imaging the dementias The Brain ~ 1.5

More information

DOSAGE FORMS AND STRENGTHS Cream: Each gram contains 10 mg of ozenoxacin (1%) (3).

DOSAGE FORMS AND STRENGTHS Cream: Each gram contains 10 mg of ozenoxacin (1%) (3). HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XEPI TM safely and effectively. See full prescribing information for XEPI TM. XEPI TM (ozenoxacin)

More information

New Research on Neuraceq TM (florbetaben F18 injection) Imaging to be Presented at Annual Alzheimer s Association International Conference

New Research on Neuraceq TM (florbetaben F18 injection) Imaging to be Presented at Annual Alzheimer s Association International Conference Media Contacts: David Patti JFK Communications dpatti@jfkhealth.com (609) 241-7365 New Research on Neuraceq TM (florbetaben F18 injection) Imaging to be Presented at Annual Alzheimer s Association International

More information

JHM-IRB Guidelines for Radiation Statements

JHM-IRB Guidelines for Radiation Statements JHM-IRB Guidelines for Radiation Statements When a participant in a research study is subjected to ionizing radiation exposure (other than that which is incidental for the standard medical management of

More information

Table 1 Principal Radiation Emission Data * Disintegration. Gamma Ka 1 X-ray

Table 1 Principal Radiation Emission Data * Disintegration. Gamma Ka 1 X-ray DESCRIPTIONGeneralGlofil-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per ml, and 0.9 percent benzyl alcohol as

More information

FULL PRESCRIBING INFORMATION

FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SODIUM IODIDE I 131 SOLUTION THERAPEUTIC safely and effectively. See full prescribing information

More information

VASCULOCIS 10 mg kit for radiopharmaceutical preparation

VASCULOCIS 10 mg kit for radiopharmaceutical preparation VASCULOCIS 10 mg kit for radiopharmaceutical preparation SUMMARY OF PRODUCT CHARACTERISTICS T0200nH 12/2012 CIS bio international, Member of IBA Molecular group of companies 1. NAME OF THE MEDICINAL PRODUCT

More information

PHYTACIS. Kit for the preparation of technetium [ 99m Tc] phytate injection USER PACKAGE LEAFLET

PHYTACIS. Kit for the preparation of technetium [ 99m Tc] phytate injection USER PACKAGE LEAFLET PHYTACIS Kit for the preparation of technetium [ 99m Tc] phytate injection USER PACKAGE LEAFLET CIS bio international, member of IBA Molecular group of companies T1800nH (T1800- T1817) 01/2017 IDENTIFICATION

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENDARI TM safely and effectively. See full prescribing information for ENDARI. ENDARI (L-glutamine

More information

Impact of training method on the robustness. of the visual assessment of 18F-florbetaben

Impact of training method on the robustness. of the visual assessment of 18F-florbetaben Impact of training method on the robustness of the visual assessment of 18F-florbetaben PET scans - results from a phase 3 study John Seibyl, 1 Ana M Catafau, 2 Henryk Barthel, 3 Kenji Ishii, 4 Christopher

More information

AdreView. Iobenguane I 123 Injection

AdreView. Iobenguane I 123 Injection AdreView Iobenguane I 123 Injection HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AdreView safely and effectively. See full prescribing information

More information

Whole-body biodistribution and radiation dosimetry estimates for the β-amyloid radioligand [ 11 C]MeS-IMPY in non-human primates

Whole-body biodistribution and radiation dosimetry estimates for the β-amyloid radioligand [ 11 C]MeS-IMPY in non-human primates Whole-body biodistribution and radiation dosimetry estimates for the β-amyloid radioligand [ 11 C]MeS-IMPY in non-human primates Molecular Imaging Branch, NIMH Bldg. 1 Rm. B3-10 September 6 th, 2006 The

More information

CONTRAINDICATIONS None. (4)

CONTRAINDICATIONS None. (4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JETREA safely and effectively. See full prescribing information for JETREA JETREA (ocriplasmin) injection,

More information

45 Hr PET Registry Review Course

45 Hr PET Registry Review Course 45 HR PET/CT REGISTRY REVIEW COURSE Course Control Document Timothy K. Marshel, MBA, R.T. (R), (N)(CT)(MR)(NCT)(PET)(CNMT) The PET/CT Training Institute, Inc. SNMMI-TS 028600-028632 45hr CEH s Voice Credits

More information

HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS. None.

HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS. None. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use safely and effectively. See full prescribing information for. ONTAK (denileukin diftitox) Injection

More information

Revised: 06/2013. Page 1

Revised: 06/2013. Page 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EXTINA Foam safely and effectively. See full prescribing information for EXTINA Foam. EXTINA (ketoconazole)

More information

FULL PRESCRIBING INFORMATION: CONTENTS*

FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRUMENBA safely and effectively. See full prescribing information for TRUMENBA. TRUMENBA (Meningococcal

More information

Ultra-TechneKow FM. Click Here to Continue. Click Here to Return to Table of Contents

Ultra-TechneKow FM. Click Here to Continue. Click Here to Return to Table of Contents Ultra-TechneKow FM Package inserts are current as of January, 1997. Contact Professional Services, 1-888-744-1414, regarding possible revisions. Click Here to Continue Click Here to Return to Table of

More information

A Guide to Talking to Your Healthcare Provider

A Guide to Talking to Your Healthcare Provider A Guide to Talking to Your Healthcare Provider About Moderate to Severe Painful Sex due to Menopause 1 What could be causing my painful sex? 2 Is this a common problem? 3 Is this serious enough to be considered

More information

Value of PET/CT in Initial Staging and Subsequent Treatment Strategy for Metastatic Breast Cancer

Value of PET/CT in Initial Staging and Subsequent Treatment Strategy for Metastatic Breast Cancer Case Study Value of PET/CT in Initial Staging and Subsequent Treatment Strategy for Metastatic Breast Cancer By Dustin Osborne, PhD, and Yong Bradley, MD, University of Tennessee, Knoxville, TN, USA Data

More information

HYDROCORTISONE OINTMENT USP,

HYDROCORTISONE OINTMENT USP, HYDROCORTISONE- hydrocortisone ointment E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ---------- HYDROCORTISONE OINTMENT USP, 1% Rx only For External Us e Only Not For Ophthalmic Us e DESCRIPTION:

More information

Core SPC for Fludeoxyglucose ( 18 F) March 2005

Core SPC for Fludeoxyglucose ( 18 F) March 2005 Core SPC for Fludeoxyglucose ( 18 F) March 2005 This FDG Core SPC has been prepared on the basis, and taking into account the available published scientific literature dated from more than 10 years. Then

More information

ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. (6)

ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. (6) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AKOVAZ safely and effectively. See full prescribing information for AKOVAZ. AKOVAZ (ephedrine sulfate

More information

DOVONEX (calcipotriene) Cream, 0.005% Rx only FOR TOPICAL DERMATOLOGIC USE ONLY. Not for Ophthalmic, Oral or Intravaginal Use.

DOVONEX (calcipotriene) Cream, 0.005% Rx only FOR TOPICAL DERMATOLOGIC USE ONLY. Not for Ophthalmic, Oral or Intravaginal Use. DOVONEX (calcipotriene) Cream, 0.005% Rx only FOR TOPICAL DERMATOLOGIC USE ONLY. Not for Ophthalmic, Oral or Intravaginal Use. DESCRIPTION Dovonex (calcipotriene) Cream, 0.005% contains calcipotriene monohydrate,

More information

INVELTYS (loteprednol etabonate ophthalmic suspension) 1%, for topical ophthalmic use Initial U.S. Approval: 1998

INVELTYS (loteprednol etabonate ophthalmic suspension) 1%, for topical ophthalmic use Initial U.S. Approval: 1998 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INVELTYS safely and effectively. See full prescribing information for INVELTYS. INVELTYS (loteprednol

More information

SODIUM IODIDE I 131 CAPSULES THERAPEUTIC 01/ Page 1 of 11

SODIUM IODIDE I 131 CAPSULES THERAPEUTIC 01/ Page 1 of 11 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SODIUM IODIDE I 131 CAPSULES THERAPEUTIC safely and effectively. See full prescribing information

More information

sanofi pasteur Influenza Virus Vaccine, H5N1

sanofi pasteur Influenza Virus Vaccine, H5N1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use, safely and effectively. See full prescribing information for. Suspension for Intramuscular Injection

More information

TECHNESCAN SESTAMIBI NAME OF THE MEDICINE DESCRIPTION. Kit for the preparation of Technetium [ 99m Tc] Sestamibi Injection

TECHNESCAN SESTAMIBI NAME OF THE MEDICINE DESCRIPTION. Kit for the preparation of Technetium [ 99m Tc] Sestamibi Injection TECHNESCAN SESTAMIBI Kit for the preparation of Technetium [ 99m Tc] Sestamibi Injection NAME OF THE MEDICINE Tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate. The abbreviated notation

More information

Administer as an intravenous infusion over 35 to 60 minutes (2.1, 2.3) Dilution required prior to administration (2.2)

Administer as an intravenous infusion over 35 to 60 minutes (2.1, 2.3) Dilution required prior to administration (2.2) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EXONDYS 51 safely and effectively. See full prescribing information for EXONDYS 51. EXONDYS 51 (eteplirsen)

More information

M A A. Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection. DIAGNOSTIC - For Intravenous Use

M A A. Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection. DIAGNOSTIC - For Intravenous Use R: March 1998 27248 0001E m TM M A A Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection DIAGNOSTIC - For Intravenous Use DESCRIPTION The kit consists of reaction vials which contain

More information

Important Safety Information for Feraheme (ferumoxytol) Injection

Important Safety Information for Feraheme (ferumoxytol) Injection Dear Radiologist: (ferumoxytol) Injection for intravenous (IV) use is an IV iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease

More information

The Ointment is back!

The Ointment is back! Now Available for Plaque Psoriasis The Ointment is back! Bioequivalent to Dovonex * Ointment Before prescribing, please see attached full Prescribing Information. The same Delivers the reliability you

More information

DOSAGE FORMS AND STRENGTHS White toothpaste containing 1.1% sodium fluoride (3)

DOSAGE FORMS AND STRENGTHS White toothpaste containing 1.1% sodium fluoride (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 3M TM ESPE TM Clinpro TM 5000 Anti-Cavity Toothpaste safely and effectively. See full prescribing

More information

JETREA CARE Provides JETREA At No Cost

JETREA CARE Provides JETREA At No Cost JETREA CARE Provides JETREA At No Cost to All Qualifying Patients Who Do Not Have Insurance JETREA CARE Patient Assistance Program Your Health Insurance Coverage No Insurance (Uninsured) Your Potential

More information

NEOSPORIN G.U. Irrigant Sterile (neomycin sulfate polymyxin B sulfate solution for irrigation)

NEOSPORIN G.U. Irrigant Sterile (neomycin sulfate polymyxin B sulfate solution for irrigation) NEOSPORIN G.U. Irrigant Sterile (neomycin sulfate polymyxin B sulfate solution for irrigation) NEOSPORIN G.U.SOLUTION NOT FOR INJECTION DESCRIPTION NEOSPORIN G.U. Irrigant is a concentrated sterile antibiotic

More information

Poltechnet GBq, radionuclide generator Sodium pertechnetate ( 99m Tc) solution

Poltechnet GBq, radionuclide generator Sodium pertechnetate ( 99m Tc) solution PACKAGE LEAFLET: INFORMATION FOR THE USER Poltechnet 8.0-175 GBq, radionuclide generator Sodium pertechnetate ( 99m Tc) solution Read all of the leaflet carefully before you are given this medicine because

More information

Revised: 03/2018. *Sections or subsections omitted from the full prescribing information are not listed.

Revised: 03/2018. *Sections or subsections omitted from the full prescribing information are not listed. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DIPROLENE Ointment safely and effectively. See full prescribing information for DIPROLENE Ointment.

More information

Indications and Usage: For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography.

Indications and Usage: For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography. INDOCYANINE GREEN - INDOCYANINE GREEN - indocyanine green injection, powder, lyophilized, for solution Novadaq Technologies Inc. ---------- Indocyanine Green for Injection USP Rx Only Description: Indocyanine

More information

Radiopharmacy. Prof. Dr. Çetin ÖNSEL. CTF Nükleer Tıp Anabilim Dalı

Radiopharmacy. Prof. Dr. Çetin ÖNSEL. CTF Nükleer Tıp Anabilim Dalı Prof. Dr. Çetin ÖNSEL CTF Nükleer Tıp Anabilim Dalı What is Nuclear Medicine? Nuclear Medicine is the branch of medicine concerned with the use of radionuclides in the study and the diagnosis of diseases.

More information

SUMMARY OF PRODUCT CHARACTERISTICS (DTPA)

SUMMARY OF PRODUCT CHARACTERISTICS (DTPA) CMR Group of Companies info@isotope-cmr.com www.isotope-cmr.com SUMMARY OF PRODUCT CHARACTERISTICS (DTPA) 1. NAME OF THE MEDICINAL PRODUCT PENTATECH lyophilized powder for injection (DTPA) 2. QUALITATIVE

More information

8 USE IN SPECIFIC POPULATIONS Patients with Open-Angle Glaucoma or Ocular Hypertension

8 USE IN SPECIFIC POPULATIONS Patients with Open-Angle Glaucoma or Ocular Hypertension 3 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Isopto Carpine safely and effectively. See full prescribing information for Isopto Carpine. Isopto

More information

Douglas J. Simpkin, Ph.D. Aurora St. Luke s Medical Center Milwaukee, Wisconsin. www.

Douglas J. Simpkin, Ph.D. Aurora St. Luke s Medical Center Milwaukee, Wisconsin. www. PET/CT Shielding Design Examples Douglas J. Simpkin, Ph.D. Aurora St. Luke s Medical Center Milwaukee, Wisconsin dsimpkin@wi.rr.com www. http://geocities.com/djsimpkin 1 Sources of Exposure: F-18 in Patients

More information

ML-00043B FULL PRESCRIBING INFORMATION: CONTENTS*

ML-00043B FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PHOTREXA VISCOUS and PHOTREXA safely and effectively. See full prescribing information for PHOTREXA

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Octreoscan Kit for preparation of 111 In-Pentetreotide 111 MBq/ ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Octreoscan is supplied

More information

For topical use only. Not for oral, ophthalmic, or intravaginal use.

For topical use only. Not for oral, ophthalmic, or intravaginal use. DESOXIMETASONE Ointment USP, 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use. Rx only DESCRIPTION Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid

More information

NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP)

NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) NEOSPORIN SOLUTION DESCRIPTION NEOSPORIN Ophthalmic Solution (neomycin and polymyxin B

More information